Sr Clinical Research Associate

About the role

As a Senior Clinical Research Associate, you will play a key role in the successful delivery of clinical trials by independently managing clinical site monitoring and site management activities across Portugal and Spain. You will act as a primary point of contact for investigative sites, ensuring compliance with protocols, ICH-GCP, and study requirements while supporting high-quality patient data. This is a senior individual contributor role that involves providing guidance and mentorship to junior CRAs.

Responsibilities

• Independently conduct and document onsite and remote monitoring activities, including site qualification, initiation, monitoring and close-out visits.
• Ensure investigative sites comply with study protocols, ICH-GCP, regulations, SOPs and project-specific requirements.
• Serve as a primary point of contact for assigned sites, managing site-related questions, issues, action items and protocol deviations.
• Review clinical trial data, source documentation and study systems to ensure accuracy, completeness, data integrity and compliance.
• Support site selection, activation and recruitment activities to achieve study milestones.
• Maintain oversight of essential study documentation, including ISF and TMF.
• Collaborate with sponsors, project teams, vendors and investigative sites to support study timelines.
• Provide mentoring and support to CRA I and II colleagues and participate in co-monitoring activities.

Required skills

• Clinical site monitoring
• ICH-GCP
• Site management
• EDC
• IRT
• eTMF
• CTMS
• Microsoft Office
• English
• Spanish

Nice to have

• Phase I-IV clinical trials
• Medidata Rave
• Oracle InForm

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Pharmacy, Nursing or a related discipline
• Master’s degree

Benefits

• Education Reimbursement program
• Monthly Cell Phone and Remote Work Allowance
• Office setup allowance
• Working while visiting program
• Flexible Summer Hours Program
• Employee referral incentive
• Alimentiv Trust
• Formal mentorship program
• Leadership development programs

About the Company

Alimentiv is a global CRO with a singular focus on advancing therapies for patients with gastrointestinal diseases. Operating as a private, profit-with-purpose company, they channel commercial success back into scientific research, technology, and their people.